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The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during rruciate ligament reconstruction procedures.

The Arthrex Tibial GraftBolt consists of a pre-packaged mating sheath and screw pair offered in three sizes. The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures.

The provided text is for a 510(k) summary for the "Arthrex Tibial GraftBolt," a bone fixation screw. This document focuses on demonstrating substantial equivalence to predicate devices based on device description and intended use, rather than presenting a study with specific acceptance criteria that the device's performance, as measured by a study, needs to meet.

Therefore, many of the requested elements for describing an acceptance criteria study are not present in the provided text. The document does not describe a performance study for the Arthrex Tibial GraftBolt that measures specific performance metrics against pre-defined acceptance criteria.

Here's a breakdown of the requested information based on the provided text, indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

• Not Available. The provided document does not contain a table of acceptance criteria or reported device performance metrics from a study. The 510(k) is based on showing substantial equivalence in design and intended use to predicate devices, not on a performance study with specific quantitative outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. No specific test set or data provenance from a study is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Available. This information is relevant to studies involving expert review for ground truth, which is not described here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Available. This is relevant to studies requiring expert adjudication, which is not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. The device is a bone fixation screw, not an AI or imaging diagnostic tool. An MRMC study is not relevant to this type of medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. The device is a bone fixation screw, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Available. No ground truth for a study is mentioned. The "ground truth" for this 510(k) process is the established safety and effectiveness of the predicate devices based on their prior clearance and market history.

8. The sample size for the training set

• Not Available. No training set for a study is mentioned.

9. How the ground truth for the training set was established

• Not Available. No training set or its ground truth establishment is mentioned.

Summary based on the provided document:

The Arthrex Tibial GraftBolt 510(k) (K093912) demonstrates substantial equivalence to predicate devices (K032167: Bio-Intrafix™ Tibial Screw and Sheath - Mitek Worldwide and K083607: AperFix® Tibial Implant with Inserter -- Cayenne Medical). The argument for substantial equivalence is based on the device's basic features and intended uses being very similar to the predicate devices. The document explicitly states: "Any differences between the Arthrex Tibial GraftBolt and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness." This type of 510(k) submission does not rely on a dedicated performance study with acceptance criteria and measured device performance in the way described in your request.

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